Atlantoaxial subluxation (AAS) is a complication of rheumatoid arthritis (RA) due to pannus formation around the odontoid process of C2 of the cervical spine. It occurs frequently in 15-30% of all RA patients. AAS may occur relatively early in the course of disease within the first years. The diagnosis of AAS identifies a patient population with a poor outcome. There is evidence that combination treatment with disease-modifying anti-rheumatic drugs (DMARD) may retard the development of AAS. However, it is not known whether treatment with inhibitors of tumor necrosis factor alpha (TNF) may lead to regression of cervical pannus and prevention or reduction of AAS.

Clinical studies analysing the effectiveness of TNF-inhibitors combined with conventional DMARD therapy, in the treatment of cervical spine involvement leading to AAS, are needed. This proposal for a pilot study aims at assessing the feasibility of an MRI-based measurement of pannus volume in patients before and after treatment with a TNF-inhibitor.

Primary objective: To show that measurements of pannus mass with MRI is feasible. Secondary objective: To assess whether pannus mass decreases measurably in patients treated with TNF-inhibitors.

This pilot study is prospective, non-randomized. The choice of therapy at any time during the study is entirely up to the treating rheumatologist.

DMARD drug and dosage is chosen by the treating physician without restriction by the study

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Adult patients with rheumatoid arthritis (RA) that have cervical involvement documented with MRI showing pannus in the atlanto-axial joint.

Criteria

Inclusion criteria:

RA fulfilling the criteria of the american college of rheumatology (ACR) (revised 1987)

18 years and older

Cervical pain

Recent MRI with detectable atlanto-axial pannus

Exclusion criteria:

Use of TNF-inhibitors 3 months prior to inclusion

Previous treatment with any biologics other than TNF-Blockers

History of inflammatory joint disease other than RA

History of active tuberculosis, histoplasmosis or listeriosis

History of lymphoma or other malignancies within 5 years

Contraindication for the use of TNF inhibitors

Comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial

History of demyelinating disorders

Persistent or recurrent infections

Pregnancy or breast feeding

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292616